Trial Outcomes & Findings for ACTIV-2: A Study for Outpatients With COVID-19 (NCT NCT04518410)
NCT ID: NCT04518410
Last Updated: 2024-08-02
Results Overview
Bamlanivimab arms: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
4044 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2024-08-02
Participant Flow
All participants were considered to be separately enrolled participants for subsequent phases of the study. BRII arms included pooled participants from Phase 2/Phase 3 to complete a Phase 3 analysis.
Participant milestones
| Measure |
Bamlanivimab 7000 mg (Phase 2)
Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 7000mg Placebo (Phase 2)
Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 2)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg Placebo (Phase 2)
Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Placebo (Phase 2)
Administered by IV infusion.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) (Phase 2)
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Placebo (Phase 2)
Administered by IM injection.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Placebo (Phase 2)
Administered by inhalation.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Placebo (Phase 2)
Administered by IV infusion.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion.
SAB-185 (3,840 Units/kg): Administered by IV infusion as a single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as a single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Placebo (Phase 2)
Administered by IV infusion.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Placebo (Phase 2)
Administered as subcutaneous (SC) injections.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
111
|
114
|
1079
|
424
|
422
|
61
|
33
|
110
|
54
|
110
|
53
|
113
|
54
|
110
|
39
|
225
|
214
|
142
|
153
|
115
|
41
|
112
|
61
|
|
Overall Study
COMPLETED
|
45
|
43
|
100
|
101
|
843
|
329
|
328
|
42
|
23
|
77
|
36
|
88
|
41
|
79
|
38
|
84
|
26
|
167
|
156
|
102
|
110
|
81
|
35
|
84
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
11
|
13
|
236
|
95
|
94
|
19
|
10
|
33
|
18
|
22
|
12
|
34
|
16
|
26
|
13
|
58
|
58
|
40
|
43
|
34
|
6
|
28
|
19
|
Reasons for withdrawal
| Measure |
Bamlanivimab 7000 mg (Phase 2)
Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 7000mg Placebo (Phase 2)
Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 2)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg Placebo (Phase 2)
Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Placebo (Phase 2)
Administered by IV infusion.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) (Phase 2)
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Placebo (Phase 2)
Administered by IM injection.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Placebo (Phase 2)
Administered by inhalation.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Placebo (Phase 2)
Administered by IV infusion.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion.
SAB-185 (3,840 Units/kg): Administered by IV infusion as a single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as a single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Placebo (Phase 2)
Administered by IV infusion.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Placebo (Phase 2)
Administered as subcutaneous (SC) injections.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
8
|
5
|
92
|
25
|
25
|
3
|
2
|
13
|
9
|
13
|
9
|
13
|
8
|
10
|
6
|
13
|
21
|
6
|
7
|
21
|
1
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
3
|
20
|
20
|
25
|
6
|
1
|
12
|
5
|
7
|
2
|
13
|
4
|
9
|
0
|
15
|
12
|
9
|
14
|
3
|
2
|
9
|
8
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
6
|
6
|
5
|
2
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
3
|
1
|
1
|
1
|
0
|
1
|
0
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
2
|
17
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
2
|
0
|
3
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
12
|
2
|
11
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
4
|
4
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Requirement to start alternative therapy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
2
|
6
|
4
|
3
|
3
|
0
|
4
|
0
|
0
|
1
|
3
|
3
|
3
|
4
|
5
|
4
|
0
|
0
|
5
|
0
|
3
|
1
|
|
Overall Study
Screen Fail but Randomized
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Excluded from analysis at NIH request (due to suspected scientific misconduct at site level)
|
0
|
0
|
0
|
0
|
81
|
37
|
23
|
4
|
6
|
3
|
4
|
0
|
0
|
4
|
0
|
1
|
1
|
21
|
16
|
21
|
19
|
3
|
2
|
4
|
2
|
|
Overall Study
Dual Enrolled Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Data missing for 92 participants
Baseline characteristics by cohort
| Measure |
Bamlanivimab 7000 mg (Phase 2)
n=48 Participants
Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 7000mg Placebo (Phase 2)
n=46 Participants
Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 2)
n=111 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg Placebo (Phase 2)
n=112 Participants
Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=383 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=396 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=54 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Placebo (Phase 2)
n=27 Participants
Administered by IV infusion.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) (Phase 2)
n=103 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Placebo (Phase 2)
n=50 Participants
Administered by IM injection.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Placebo (Phase 2)
n=52 Participants
Administered by inhalation.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Placebo (Phase 2)
n=51 Participants
Administered as oral tablets.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Placebo (Phase 2)
n=34 Participants
Administered by IV infusion.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=194 Participants
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
n=121 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) NON-OMICRON Population
n=134 Participants
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (High Dose) (Phase 2)
n=107 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Placebo (Phase 2)
n=39 Participants
Administered by IV infusion.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Placebo (Phase 2)
n=58 Participants
Administered as subcutaneous (SC) injections.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Total
n=3735 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 15.80 • n=48 Participants
|
41.5 years
STANDARD_DEVIATION 13.79 • n=46 Participants
|
45.2 years
STANDARD_DEVIATION 13.52 • n=111 Participants
|
46.7 years
STANDARD_DEVIATION 13.69 • n=112 Participants
|
51.1 years
STANDARD_DEVIATION 15.92 • n=990 Participants
|
47.8 years
STANDARD_DEVIATION 13.59 • n=383 Participants
|
48.7 years
STANDARD_DEVIATION 13.68 • n=396 Participants
|
42.5 years
STANDARD_DEVIATION 12.06 • n=54 Participants
|
44.6 years
STANDARD_DEVIATION 13.63 • n=27 Participants
|
39.9 years
STANDARD_DEVIATION 11.80 • n=103 Participants
|
36.8 years
STANDARD_DEVIATION 12.07 • n=50 Participants
|
40.2 years
STANDARD_DEVIATION 12.37 • n=110 Participants
|
40.1 years
STANDARD_DEVIATION 12.05 • n=52 Participants
|
37.7 years
STANDARD_DEVIATION 12.72 • n=106 Participants
|
38.5 years
STANDARD_DEVIATION 11.57 • n=51 Participants
|
39.0 years
STANDARD_DEVIATION 10.94 • n=106 Participants
|
37.3 years
STANDARD_DEVIATION 11.22 • n=34 Participants
|
50.1 years
STANDARD_DEVIATION 14.23 • n=198 Participants
|
52.8 years
STANDARD_DEVIATION 15.86 • n=194 Participants
|
54.9 years
STANDARD_DEVIATION 13.12 • n=121 Participants
|
52.7 years
STANDARD_DEVIATION 14.16 • n=134 Participants
|
39.9 years
STANDARD_DEVIATION 12.47 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 14.88 • n=39 Participants
|
42.8 years
STANDARD_DEVIATION 14.57 • n=105 Participants
|
41.4 years
STANDARD_DEVIATION 13.02 • n=58 Participants
|
47.2 years
STANDARD_DEVIATION 14.99 • n=3735 Participants
|
|
Age, Customized
Younger than 55
|
30 Participants
n=48 Participants
|
35 Participants
n=46 Participants
|
84 Participants
n=111 Participants
|
81 Participants
n=112 Participants
|
582 Participants
n=990 Participants
|
254 Participants
n=383 Participants
|
256 Participants
n=396 Participants
|
45 Participants
n=54 Participants
|
21 Participants
n=27 Participants
|
92 Participants
n=103 Participants
|
46 Participants
n=50 Participants
|
98 Participants
n=110 Participants
|
44 Participants
n=52 Participants
|
97 Participants
n=106 Participants
|
44 Participants
n=51 Participants
|
100 Participants
n=106 Participants
|
32 Participants
n=34 Participants
|
115 Participants
n=198 Participants
|
105 Participants
n=194 Participants
|
52 Participants
n=121 Participants
|
62 Participants
n=134 Participants
|
92 Participants
n=107 Participants
|
32 Participants
n=39 Participants
|
84 Participants
n=105 Participants
|
48 Participants
n=58 Participants
|
2531 Participants
n=3735 Participants
|
|
Age, Customized
55 or older
|
18 Participants
n=48 Participants
|
11 Participants
n=46 Participants
|
27 Participants
n=111 Participants
|
31 Participants
n=112 Participants
|
408 Participants
n=990 Participants
|
129 Participants
n=383 Participants
|
140 Participants
n=396 Participants
|
9 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
11 Participants
n=103 Participants
|
4 Participants
n=50 Participants
|
12 Participants
n=110 Participants
|
8 Participants
n=52 Participants
|
9 Participants
n=106 Participants
|
7 Participants
n=51 Participants
|
6 Participants
n=106 Participants
|
2 Participants
n=34 Participants
|
83 Participants
n=198 Participants
|
89 Participants
n=194 Participants
|
69 Participants
n=121 Participants
|
72 Participants
n=134 Participants
|
15 Participants
n=107 Participants
|
7 Participants
n=39 Participants
|
21 Participants
n=105 Participants
|
10 Participants
n=58 Participants
|
1204 Participants
n=3735 Participants
|
|
Age, Customized
Younger than 60
|
37 Participants
n=48 Participants
|
42 Participants
n=46 Participants
|
98 Participants
n=111 Participants
|
93 Participants
n=112 Participants
|
691 Participants
n=990 Participants
|
302 Participants
n=383 Participants
|
303 Participants
n=396 Participants
|
50 Participants
n=54 Participants
|
22 Participants
n=27 Participants
|
99 Participants
n=103 Participants
|
49 Participants
n=50 Participants
|
106 Participants
n=110 Participants
|
49 Participants
n=52 Participants
|
103 Participants
n=106 Participants
|
48 Participants
n=51 Participants
|
102 Participants
n=106 Participants
|
34 Participants
n=34 Participants
|
146 Participants
n=198 Participants
|
131 Participants
n=194 Participants
|
76 Participants
n=121 Participants
|
93 Participants
n=134 Participants
|
100 Participants
n=107 Participants
|
34 Participants
n=39 Participants
|
90 Participants
n=105 Participants
|
52 Participants
n=58 Participants
|
2950 Participants
n=3735 Participants
|
|
Age, Customized
60 or older
|
11 Participants
n=48 Participants
|
4 Participants
n=46 Participants
|
13 Participants
n=111 Participants
|
19 Participants
n=112 Participants
|
299 Participants
n=990 Participants
|
81 Participants
n=383 Participants
|
93 Participants
n=396 Participants
|
4 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=103 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=110 Participants
|
3 Participants
n=52 Participants
|
3 Participants
n=106 Participants
|
3 Participants
n=51 Participants
|
4 Participants
n=106 Participants
|
0 Participants
n=34 Participants
|
52 Participants
n=198 Participants
|
63 Participants
n=194 Participants
|
45 Participants
n=121 Participants
|
41 Participants
n=134 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=39 Participants
|
15 Participants
n=105 Participants
|
6 Participants
n=58 Participants
|
785 Participants
n=3735 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=48 Participants
|
23 Participants
n=46 Participants
|
54 Participants
n=111 Participants
|
56 Participants
n=112 Participants
|
515 Participants
n=990 Participants
|
197 Participants
n=383 Participants
|
209 Participants
n=396 Participants
|
33 Participants
n=54 Participants
|
16 Participants
n=27 Participants
|
51 Participants
n=103 Participants
|
30 Participants
n=50 Participants
|
66 Participants
n=110 Participants
|
26 Participants
n=52 Participants
|
62 Participants
n=106 Participants
|
26 Participants
n=51 Participants
|
62 Participants
n=106 Participants
|
16 Participants
n=34 Participants
|
108 Participants
n=198 Participants
|
107 Participants
n=194 Participants
|
72 Participants
n=121 Participants
|
67 Participants
n=134 Participants
|
59 Participants
n=107 Participants
|
22 Participants
n=39 Participants
|
57 Participants
n=105 Participants
|
29 Participants
n=58 Participants
|
1989 Participants
n=3735 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=48 Participants
|
23 Participants
n=46 Participants
|
57 Participants
n=111 Participants
|
56 Participants
n=112 Participants
|
475 Participants
n=990 Participants
|
186 Participants
n=383 Participants
|
187 Participants
n=396 Participants
|
21 Participants
n=54 Participants
|
11 Participants
n=27 Participants
|
52 Participants
n=103 Participants
|
20 Participants
n=50 Participants
|
44 Participants
n=110 Participants
|
26 Participants
n=52 Participants
|
44 Participants
n=106 Participants
|
25 Participants
n=51 Participants
|
44 Participants
n=106 Participants
|
18 Participants
n=34 Participants
|
90 Participants
n=198 Participants
|
87 Participants
n=194 Participants
|
49 Participants
n=121 Participants
|
67 Participants
n=134 Participants
|
48 Participants
n=107 Participants
|
17 Participants
n=39 Participants
|
48 Participants
n=105 Participants
|
29 Participants
n=58 Participants
|
1746 Participants
n=3735 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=48 Participants
|
17 Participants
n=46 Participants
|
18 Participants
n=111 Participants
|
31 Participants
n=112 Participants
|
328 Participants
n=990 Participants
|
190 Participants
n=383 Participants
|
191 Participants
n=396 Participants
|
24 Participants
n=54 Participants
|
13 Participants
n=27 Participants
|
49 Participants
n=103 Participants
|
16 Participants
n=50 Participants
|
58 Participants
n=110 Participants
|
27 Participants
n=52 Participants
|
58 Participants
n=106 Participants
|
27 Participants
n=51 Participants
|
45 Participants
n=106 Participants
|
18 Participants
n=34 Participants
|
117 Participants
n=198 Participants
|
100 Participants
n=194 Participants
|
62 Participants
n=121 Participants
|
55 Participants
n=134 Participants
|
44 Participants
n=107 Participants
|
22 Participants
n=39 Participants
|
54 Participants
n=105 Participants
|
37 Participants
n=58 Participants
|
1616 Participants
n=3735 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=48 Participants
|
28 Participants
n=46 Participants
|
93 Participants
n=111 Participants
|
79 Participants
n=112 Participants
|
660 Participants
n=990 Participants
|
193 Participants
n=383 Participants
|
205 Participants
n=396 Participants
|
30 Participants
n=54 Participants
|
14 Participants
n=27 Participants
|
54 Participants
n=103 Participants
|
34 Participants
n=50 Participants
|
52 Participants
n=110 Participants
|
25 Participants
n=52 Participants
|
48 Participants
n=106 Participants
|
24 Participants
n=51 Participants
|
61 Participants
n=106 Participants
|
16 Participants
n=34 Participants
|
81 Participants
n=198 Participants
|
94 Participants
n=194 Participants
|
59 Participants
n=121 Participants
|
79 Participants
n=134 Participants
|
63 Participants
n=107 Participants
|
17 Participants
n=39 Participants
|
51 Participants
n=105 Participants
|
21 Participants
n=58 Participants
|
2114 Participants
n=3735 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=48 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=111 Participants
|
2 Participants
n=112 Participants
|
2 Participants
n=990 Participants
|
0 Participants
n=383 Participants
|
0 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=110 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=194 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
5 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=48 Participants
|
5 Participants
n=46 Participants
|
2 Participants
n=111 Participants
|
4 Participants
n=112 Participants
|
57 Participants
n=990 Participants
|
15 Participants
n=383 Participants
|
22 Participants
n=396 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=103 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=110 Participants
|
3 Participants
n=52 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=51 Participants
|
4 Participants
n=106 Participants
|
1 Participants
n=34 Participants
|
4 Participants
n=198 Participants
|
1 Participants
n=194 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
134 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
3 Participants
n=990 Participants
|
0 Participants
n=383 Participants
|
1 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=110 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=34 Participants
|
8 Participants
n=198 Participants
|
10 Participants
n=194 Participants
|
2 Participants
n=121 Participants
|
4 Participants
n=134 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
32 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=48 Participants
|
2 Participants
n=46 Participants
|
13 Participants
n=111 Participants
|
10 Participants
n=112 Participants
|
63 Participants
n=990 Participants
|
79 Participants
n=383 Participants
|
62 Participants
n=396 Participants
|
9 Participants
n=54 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=103 Participants
|
8 Participants
n=50 Participants
|
13 Participants
n=110 Participants
|
3 Participants
n=52 Participants
|
4 Participants
n=106 Participants
|
7 Participants
n=51 Participants
|
9 Participants
n=106 Participants
|
1 Participants
n=34 Participants
|
17 Participants
n=198 Participants
|
16 Participants
n=194 Participants
|
4 Participants
n=121 Participants
|
12 Participants
n=134 Participants
|
15 Participants
n=107 Participants
|
1 Participants
n=39 Participants
|
10 Participants
n=105 Participants
|
8 Participants
n=58 Participants
|
381 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=111 Participants
|
2 Participants
n=112 Participants
|
7 Participants
n=990 Participants
|
4 Participants
n=383 Participants
|
2 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=103 Participants
|
1 Participants
n=50 Participants
|
5 Participants
n=110 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=198 Participants
|
1 Participants
n=194 Participants
|
1 Participants
n=121 Participants
|
1 Participants
n=134 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
34 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
3 Participants
n=990 Participants
|
1 Participants
n=383 Participants
|
1 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=110 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=194 Participants
|
1 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
8 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=48 Participants
|
2 Participants
n=46 Participants
|
3 Participants
n=111 Participants
|
3 Participants
n=112 Participants
|
16 Participants
n=990 Participants
|
14 Participants
n=383 Participants
|
15 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=103 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=110 Participants
|
5 Participants
n=52 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=106 Participants
|
1 Participants
n=34 Participants
|
11 Participants
n=198 Participants
|
10 Participants
n=194 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=105 Participants
|
1 Participants
n=58 Participants
|
100 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=48 Participants
|
37 Participants
n=46 Participants
|
92 Participants
n=111 Participants
|
92 Participants
n=112 Participants
|
840 Participants
n=990 Participants
|
270 Participants
n=383 Participants
|
293 Participants
n=396 Participants
|
44 Participants
n=54 Participants
|
21 Participants
n=27 Participants
|
85 Participants
n=103 Participants
|
38 Participants
n=50 Participants
|
85 Participants
n=110 Participants
|
40 Participants
n=52 Participants
|
95 Participants
n=106 Participants
|
42 Participants
n=51 Participants
|
89 Participants
n=106 Participants
|
30 Participants
n=34 Participants
|
156 Participants
n=198 Participants
|
154 Participants
n=194 Participants
|
113 Participants
n=121 Participants
|
117 Participants
n=134 Participants
|
86 Participants
n=107 Participants
|
38 Participants
n=39 Participants
|
90 Participants
n=105 Participants
|
49 Participants
n=58 Participants
|
3037 Participants
n=3735 Participants
|
|
Race/Ethnicity, Customized
Not collected or reported
|
0 Participants
n=48 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=111 Participants
|
1 Participants
n=112 Participants
|
1 Participants
n=990 Participants
|
0 Participants
n=383 Participants
|
0 Participants
n=396 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=110 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=198 Participants
|
2 Participants
n=194 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=39 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
10 Participants
n=3735 Participants
|
|
Baseline BMI (kg/m2 )
|
28.4 kg/m2
STANDARD_DEVIATION 4.62 • n=42 Participants • Data missing for 92 participants
|
29.2 kg/m2
STANDARD_DEVIATION 7.20 • n=39 Participants • Data missing for 92 participants
|
29.7 kg/m2
STANDARD_DEVIATION 6.08 • n=95 Participants • Data missing for 92 participants
|
28.3 kg/m2
STANDARD_DEVIATION 6.28 • n=97 Participants • Data missing for 92 participants
|
29.5 kg/m2
STANDARD_DEVIATION 6.81 • n=961 Participants • Data missing for 92 participants
|
30.7 kg/m2
STANDARD_DEVIATION 7.44 • n=377 Participants • Data missing for 92 participants
|
31.4 kg/m2
STANDARD_DEVIATION 7.25 • n=394 Participants • Data missing for 92 participants
|
32.8 kg/m2
STANDARD_DEVIATION 8.70 • n=53 Participants • Data missing for 92 participants
|
30.3 kg/m2
STANDARD_DEVIATION 7.81 • n=26 Participants • Data missing for 92 participants
|
28.9 kg/m2
STANDARD_DEVIATION 5.94 • n=103 Participants • Data missing for 92 participants
|
28.7 kg/m2
STANDARD_DEVIATION 5.47 • n=50 Participants • Data missing for 92 participants
|
27.9 kg/m2
STANDARD_DEVIATION 6.95 • n=108 Participants • Data missing for 92 participants
|
27.9 kg/m2
STANDARD_DEVIATION 5.20 • n=52 Participants • Data missing for 92 participants
|
28.4 kg/m2
STANDARD_DEVIATION 6.26 • n=105 Participants • Data missing for 92 participants
|
27.4 kg/m2
STANDARD_DEVIATION 4.93 • n=51 Participants • Data missing for 92 participants
|
28.0 kg/m2
STANDARD_DEVIATION 7.37 • n=103 Participants • Data missing for 92 participants
|
27.8 kg/m2
STANDARD_DEVIATION 6.01 • n=33 Participants • Data missing for 92 participants
|
32.9 kg/m2
STANDARD_DEVIATION 7.84 • n=198 Participants • Data missing for 92 participants
|
33.1 kg/m2
STANDARD_DEVIATION 7.59 • n=194 Participants • Data missing for 92 participants
|
31.3 kg/m2
STANDARD_DEVIATION 6.49 • n=121 Participants • Data missing for 92 participants
|
33.7 kg/m2
STANDARD_DEVIATION 7.09 • n=134 Participants • Data missing for 92 participants
|
28.1 kg/m2
STANDARD_DEVIATION 6.13 • n=105 Participants • Data missing for 92 participants
|
29.4 kg/m2
STANDARD_DEVIATION 4.44 • n=39 Participants • Data missing for 92 participants
|
28.0 kg/m2
STANDARD_DEVIATION 5.43 • n=105 Participants • Data missing for 92 participants
|
27.1 kg/m2
STANDARD_DEVIATION 4.63 • n=58 Participants • Data missing for 92 participants
|
30.1 kg/m2
STANDARD_DEVIATION 7.03 • n=3643 Participants • Data missing for 92 participants
|
|
BMI category (kg/m2 )
Less than or equal to 35 kg/m2
|
38 Participants
n=48 Participants
|
34 Participants
n=46 Participants
|
77 Participants
n=111 Participants
|
86 Participants
n=112 Participants
|
799 Participants
n=990 Participants
|
278 Participants
n=383 Participants
|
279 Participants
n=396 Participants
|
31 Participants
n=54 Participants
|
19 Participants
n=27 Participants
|
89 Participants
n=103 Participants
|
45 Participants
n=50 Participants
|
99 Participants
n=110 Participants
|
48 Participants
n=52 Participants
|
94 Participants
n=106 Participants
|
50 Participants
n=51 Participants
|
95 Participants
n=106 Participants
|
30 Participants
n=34 Participants
|
116 Participants
n=198 Participants
|
117 Participants
n=194 Participants
|
81 Participants
n=121 Participants
|
73 Participants
n=134 Participants
|
92 Participants
n=107 Participants
|
35 Participants
n=39 Participants
|
96 Participants
n=105 Participants
|
56 Participants
n=58 Participants
|
2857 Participants
n=3735 Participants
|
|
BMI category (kg/m2 )
Greater than 35 kg/m2
|
4 Participants
n=48 Participants
|
5 Participants
n=46 Participants
|
18 Participants
n=111 Participants
|
11 Participants
n=112 Participants
|
162 Participants
n=990 Participants
|
99 Participants
n=383 Participants
|
115 Participants
n=396 Participants
|
22 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=103 Participants
|
5 Participants
n=50 Participants
|
9 Participants
n=110 Participants
|
4 Participants
n=52 Participants
|
11 Participants
n=106 Participants
|
1 Participants
n=51 Participants
|
8 Participants
n=106 Participants
|
3 Participants
n=34 Participants
|
82 Participants
n=198 Participants
|
77 Participants
n=194 Participants
|
40 Participants
n=121 Participants
|
61 Participants
n=134 Participants
|
13 Participants
n=107 Participants
|
4 Participants
n=39 Participants
|
9 Participants
n=105 Participants
|
2 Participants
n=58 Participants
|
786 Participants
n=3735 Participants
|
|
BMI category (kg/m2 )
Participants with missing data
|
6 Participants
n=48 Participants
|
7 Participants
n=46 Participants
|
16 Participants
n=111 Participants
|
15 Participants
n=112 Participants
|
29 Participants
n=990 Participants
|
6 Participants
n=383 Participants
|
2 Participants
n=396 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=110 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=194 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=134 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=58 Participants
|
92 Participants
n=3735 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
Bamlanivimab arms: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=110 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=105 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=103 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=107 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=102 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=103 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=111 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=55 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=51 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
COVID-19 Symptom Duration (Phase 2)
|
9.0 Days
Interval 8.0 to 12.0
|
9 Days
Interval 8.0 to 12.0
|
9 Days
Interval 8.0 to 13.0
|
11.0 Days
Interval 10.0 to 13.0
|
10.0 Days
Interval 8.0 to 13.0
|
8.0 Days
Interval 7.0 to 10.0
|
10.0 Days
Interval 8.0 to 13.0
|
8.0 Days
Interval 6.0 to 10.0
|
10.0 Days
Interval 8.0 to 13.0
|
21.0 Days
Lilly agent symptom duration is analyzed differently from other agents and the median reported is descriptive median without associated probability distribution. Hence 95% CI is not applicable here.
Inter-Quartile Range 21 is reported instead for Lilly agent arms.
|
18.5 Days
Lilly agent symptom duration is analyzed differently from other agents and the median reported is descriptive median without associated probability distribution. Hence 95% CI is not applicable here.
Inter-Quartile Range 21 is reported instead for Lilly agent arms.
|
24.0 Days
Lilly agent symptom duration is analyzed differently from other agents and the median reported is descriptive median without associated probability distribution. Hence 95% CI is not applicable here.
Inter-Quartile Range 14 is reported instead for Lilly agent arms.
|
20.5 Days
Lilly agent symptom duration is analyzed differently from other agents and the median reported is descriptive median without associated probability distribution. Hence 95% CI is not applicable here.
Inter-Quartile Range 19 is reported instead for Lilly agent arms.
|
8.00 Days
Interval 7.0 to 12.0
|
10.00 Days
Interval 8.0 to 13.0
|
11.00 Days
Interval 9.0 to 15.0
|
10.00 Days
Interval 7.0 to 15.0
|
13.0 Days
Interval 10.0 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=94 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=88 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=80 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=83 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=89 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=91 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=88 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=46 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=44 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=105 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=83 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=88 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=49 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=44 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=93 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Undetected (less than LLOQ)
|
37 Participants
|
28 Participants
|
32 Participants
|
39 Participants
|
34 Participants
|
35 Participants
|
32 Participants
|
42 Participants
|
44 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
26 Participants
|
36 Participants
|
25 Participants
|
23 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Detected (greater than or equal to LLOQ)
|
57 Participants
|
60 Participants
|
48 Participants
|
44 Participants
|
55 Participants
|
56 Participants
|
56 Participants
|
46 Participants
|
49 Participants
|
38 Participants
|
36 Participants
|
97 Participants
|
100 Participants
|
57 Participants
|
52 Participants
|
24 Participants
|
21 Participants
|
67 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Participants with missing records or excluded due to unsuitable sample specimen conditions
|
16 Participants
|
18 Participants
|
25 Participants
|
23 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
14 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
20 Participants
|
23 Participants
|
6 Participants
|
7 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=94 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=84 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=89 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=91 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=83 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=93 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=82 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=46 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=43 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=104 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=106 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=83 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=93 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=47 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=44 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=93 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Detected (greater than or equal to LLOQ)
|
32 Participants
|
31 Participants
|
29 Participants
|
28 Participants
|
29 Participants
|
24 Participants
|
30 Participants
|
19 Participants
|
24 Participants
|
35 Participants
|
33 Participants
|
91 Participants
|
89 Participants
|
17 Participants
|
34 Participants
|
12 Participants
|
13 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Undetected (less than LLOQ)
|
62 Participants
|
53 Participants
|
60 Participants
|
63 Participants
|
54 Participants
|
69 Participants
|
52 Participants
|
71 Participants
|
64 Participants
|
11 Participants
|
10 Participants
|
13 Participants
|
17 Participants
|
66 Participants
|
59 Participants
|
35 Participants
|
31 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Participants with missing records or excluded due to unsuitable sample specimen conditions
|
16 Participants
|
22 Participants
|
16 Participants
|
15 Participants
|
20 Participants
|
14 Participants
|
20 Participants
|
15 Participants
|
19 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
20 Participants
|
18 Participants
|
8 Participants
|
7 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=91 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=84 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=85 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=90 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=86 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=91 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=84 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=46 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=42 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=100 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=82 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=91 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=46 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=45 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=94 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Undetected (less than LLOQ)
|
83 Participants
|
73 Participants
|
75 Participants
|
81 Participants
|
81 Participants
|
85 Participants
|
78 Participants
|
82 Participants
|
85 Participants
|
24 Participants
|
28 Participants
|
35 Participants
|
33 Participants
|
70 Participants
|
81 Participants
|
44 Participants
|
42 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Detected (greater than or equal to LLOQ)
|
8 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
22 Participants
|
14 Participants
|
65 Participants
|
69 Participants
|
12 Participants
|
10 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 2)
Participants with missing records or excluded due to unsuitable sample specimen conditions
|
19 Participants
|
22 Participants
|
20 Participants
|
16 Participants
|
17 Participants
|
16 Participants
|
18 Participants
|
15 Participants
|
15 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
10 Participants
|
21 Participants
|
20 Participants
|
9 Participants
|
6 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Thru Day 28Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=110 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=105 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=103 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=107 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=102 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=103 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=111 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=55 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=51 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
|
9 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
15 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Thru Day 28Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=383 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=397 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=134 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=194 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35 Events
|
8 Events
|
44 Events
|
5 Events
|
3 Events
|
—
|
3 Events
|
6 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Thru Day 28Population: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=383 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=397 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=134 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=194 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
71 Participants
|
30 Participants
|
67 Participants
|
28 Participants
|
20 Participants
|
—
|
16 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description (Phase 3): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
Bamlanivimab arm: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=383 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=397 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=134 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=194 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
COVID-19 Symptom Duration (Phase 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.5 Days
Lilly agent symptom duration is analyzed differently from other agents and the median reported is descriptive median without associated probability distribution. Hence 95% CI is not applicable here. Inter-Quartile Range 18 is reported instead for Lilly agent arms.
|
11.0 Days
Interval 10.0 to 12.0
|
11.0 Days
Interval 10.0 to 13.0
|
11.0 Days
Interval 9.0 to 13.0
|
14.0 Days
Interval 9.0 to 16.0
|
—
|
13.00 Days
Interval 10.0 to 15.0
|
11.0 Days
Interval 9.0 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: Analysis population description (Phase 3): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms = pooled placebo data. BRII-196+BRII-198 data is Ph2 subjects only. Bamlanivimab 700mg (Ph3) enrolled under Prot. v1, OM new in v8 so OM not pre-specified, not done. Participants missing records or unsuitable sample specimen conditions excluded.
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=100 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=93 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=166 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=120 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=158 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=113 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantification of SARS-CoV-2 RNA (Phase 3)
Undetected (less than LLOQ)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37 Participants
|
35 Participants
|
47 Participants
|
51 Participants
|
—
|
47 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 3)
Detected (greater than or equal to LLOQ)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
63 Participants
|
58 Participants
|
119 Participants
|
69 Participants
|
—
|
111 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Quantification of SARS-CoV-2 RNA (Phase 3)
Participants with missing records or excluded due to unsuitable sample specimen conditions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12 Participants
|
16 Participants
|
32 Participants
|
14 Participants
|
—
|
36 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description (Phase 2): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All placebo arms except for Bamlanivimab include pooled placebo data.
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=110 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=105 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=103 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=107 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=102 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=103 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=111 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=55 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=51 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
|
7 Events
|
6 Events
|
5 Events
|
2 Events
|
4 Events
|
5 Events
|
4 Events
|
6 Events
|
4 Events
|
2 Events
|
4 Events
|
4 Events
|
4 Events
|
4 Events
|
7 Events
|
0 Events
|
4 Events
|
1 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description (Phase 3): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, BRII enrolled under v6 or earlier, this OM was a new addition in v8 so this OM was not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=134 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=194 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Events
|
2 Events
|
—
|
3 Events
|
6 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 14Population: Analysis population description (Phase 2): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Participants with missing or unsuitable samples were excluded from analysis. All placebo arms except for Bamlanivimab include pooled placebo data.
Measured from staff-collected NP swabs
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=91 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=84 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=85 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=90 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=86 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=91 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=84 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=90 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=92 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=46 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=42 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=100 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=82 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=91 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=46 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=45 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=94 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
|
1.114 log 10 copies/mL
Standard Deviation 0.6786
|
1.315 log 10 copies/mL
Standard Deviation 0.7722
|
1.316 log 10 copies/mL
Standard Deviation 0.7152
|
1.095 log 10 copies/mL
Standard Deviation 0.8025
|
0.953 log 10 copies/mL
Standard Deviation 0.5247
|
0.950 log 10 copies/mL
Standard Deviation 0.6005
|
0.976 log 10 copies/mL
Standard Deviation 0.5428
|
1.1 log 10 copies/mL
Standard Deviation NA
Standard deviation not calculated by BMS. Interquartile range is 0.70 to 1.70.
|
1.0 log 10 copies/mL
Standard Deviation NA
Standard deviation not calculated by BMS. Interquartile range is 0.70 to 0.70.
|
1.357 log 10 copies/mL
Standard Deviation 0.8371
|
1.201 log 10 copies/mL
Standard Deviation 0.8123
|
1.669 log 10 copies/mL
Standard Deviation 1.0883
|
1.552 log 10 copies/mL
Standard Deviation 0.7373
|
1.20 log 10 copies/mL
Standard Deviation 0.857
|
1.32 log 10 copies/mL
Standard Deviation 0.740
|
1.09 log 10 copies/mL
Standard Deviation 0.565
|
1.15 log 10 copies/mL
Standard Deviation 0.655
|
1.051 log 10 copies/mL
Standard Deviation 0.6425
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, this OM was a new addition in v7 so this OM was not pre-specified and therefore not done. Participants with missing records or excluded due to unsuitable sample specimen conditions.
Measured from staff-collected NP swabs
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=100 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=93 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=166 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=120 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=158 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=113 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.899 log 10 copies/mL
Standard Deviation 1.5822
|
3.122 log 10 copies/mL
Standard Deviation 2.0459
|
3.960 log 10 copies/mL
Standard Deviation 2.1722
|
2.935 log 10 copies/mL
Standard Deviation 2.0670
|
—
|
3.857 log 10 copies/mL
Standard Deviation 2.2445
|
2.745 log 10 copies/mL
Standard Deviation 2.1912
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Bamlanivimab Ph2\&3 enrolled under v1, Camostat, SNG001, SAB Ph2 enrolled under Protocol v6 or earlier, this OM was a new addition in protocol v8 so this OM was not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=134 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=194 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
|
16.00 Days
Interval 14.0 to 18.0
|
14.00 Days
Interval 12.0 to 17.0
|
—
|
—
|
16.0 Days
Interval 15.0 to 21.0
|
24.0 Days
Interval 17.0 to
The upper confidence interval from the Kaplan-Meier product-limit-estimates is not available as there are not enough events during the later timepoints in the study. Consequently, the median and/or confidence limit could not be statistically estimated.
|
—
|
—
|
8.0 Days
Interval 6.0 to 10.0
|
—
|
—
|
—
|
—
|
23.0 Days
Interval 19.0 to 25.0
|
16.00 Days
Interval 11.0 to 22.0
|
—
|
19.0 Days
Interval 16.0 to 23.0
|
17.00 Days
Interval 11.0 to 23.0
|
10.0 Days
Interval 8.0 to 13.0
|
18.0 Days
Interval 16.0 to 21.0
|
NA Days
Interval 20.0 to
The median and upper confidence interval from the Kaplan-Meier product-limit-estimates are not available as there are not enough events beyond the halfway timepoint in the study. Consequently, the median and/or confidence limit could not be statistically estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40. Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=198 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=990 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=194 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=121 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=134 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=107 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=102 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=105 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=107 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
COVID-19 Symptom Severity Ranking (Phases 2 and 3)
|
4.6 units on a scale*days
Standard Deviation 8.16
|
5.5 units on a scale*days
Standard Deviation 9.74
|
3.6360 units on a scale*days
Standard Deviation 4.67064
|
5.5345 units on a scale*days
Standard Deviation 9.68874
|
5.3314 units on a scale*days
Standard Deviation 9.41155
|
5.1306 units on a scale*days
Standard Deviation 8.69588
|
4.1020 units on a scale*days
Standard Deviation 6.33252
|
4.5759 units on a scale*days
Standard Deviation 7.82761
|
4.7658 units on a scale*days
Standard Deviation 6.71588
|
3.4940 units on a scale*days
Standard Deviation 7.83544
|
5.6939 units on a scale*days
Standard Deviation 11.09572
|
4.1395 units on a scale*days
Standard Deviation 7.35047
|
4.0378 units on a scale*days
Standard Deviation 7.37122
|
7.8505 units on a scale*days
Standard Deviation 12.16647
|
3.5 units on a scale*days
Standard Deviation 3.35
|
4.4001 units on a scale*days
Standard Deviation 7.42311
|
4.1213 units on a scale*days
Standard Deviation 6.12801
|
5.8 units on a scale*days
Standard Deviation 10.44
|
5.0532 units on a scale*days
Standard Deviation 6.03326
|
5.6263 units on a scale*days
Standard Deviation 8.89389
|
4.5862 units on a scale*days
Standard Deviation 6.27948
|
4.6631 units on a scale*days
Standard Deviation 8.38511
|
4.5728 units on a scale*days
Standard Deviation 7.87041
|
4.6 units on a scale*days
Standard Deviation 7.51
|
4.2 units on a scale*days
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=990 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
|
87 Participants
|
96 Participants
|
86 Participants
|
92 Participants
|
82 Participants
|
92 Participants
|
81 Participants
|
81 Participants
|
102 Participants
|
42 Participants
|
40 Participants
|
102 Participants
|
105 Participants
|
321 Participants
|
42 Participants
|
876 Participants
|
323 Participants
|
43 Participants
|
119 Participants
|
83 Participants
|
79 Participants
|
70 Participants
|
86 Participants
|
160 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). This OM was not a pre-specified outcome for all Bamlanivimab arms (Phase 2 \& 3) and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not analyzed for Bamlanivimab Phase 2 and Phase 3 arms.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
|
14.00 Days
Interval 8.0 to 16.0
|
13.00 Days
Interval 11.0 to 16.0
|
19.0 Days
Interval 17.0 to 24.0
|
17.0 Days
Interval 13.0 to 19.0
|
12.0 Days
Interval 10.0 to 16.0
|
14.0 Days
Interval 11.0 to 17.0
|
15.0 Days
Interval 12.0 to 21.0
|
17.0 Days
Interval 14.0 to 22.0
|
11.0 Days
Interval 10.0 to 15.0
|
—
|
—
|
—
|
—
|
22.0 Days
Interval 18.0 to 26.0
|
11.00 Days
Interval 7.0 to 15.0
|
—
|
16.0 Days
Interval 14.0 to 19.0
|
15.00 Days
Interval 8.0 to 19.0
|
12.0 Days
Interval 9.0 to 17.0
|
12.0 Days
Interval 9.0 to 18.0
|
17.0 Days
Interval 14.0 to 21.0
|
12.0 Days
Interval 10.0 to 16.0
|
17.0 Days
Interval 12.0 to 19.0
|
15.0 Days
Interval 12.0 to 18.0
|
13.0 Days
Interval 10.0 to 16.0
|
SECONDARY outcome
Timeframe: Day 0 thru Week 24Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). BRII-196+BRII-198 Placebo includes pooled placebo data.
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=990 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
|
5 Events
|
8 Events
|
2 Events
|
7 Events
|
6 Events
|
6 Events
|
3 Events
|
5 Events
|
7 Events
|
2 Events
|
4 Events
|
5 Events
|
5 Events
|
46 Events
|
1 Events
|
44 Events
|
13 Events
|
5 Events
|
8 Events
|
5 Events
|
5 Events
|
7 Events
|
5 Events
|
6 Events
|
5 Events
|
SECONDARY outcome
Timeframe: Day 0 thru Week 72Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). All Bamlanivimab arms (Phase 2 \& 3) were only 24 week-long studies, therefore this OM was not a pre-specified outcome and is not applicable. BRII-196+BRII-198 Placebo includes pooled placebo data.
Not applicable to Bamlanivimab arms as these were only 24 week-long studies. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
|
7 Events
|
8 Events
|
2 Events
|
7 Events
|
9 Events
|
6 Events
|
4 Events
|
5 Events
|
11 Events
|
—
|
—
|
—
|
—
|
59 Events
|
3 Events
|
—
|
23 Events
|
5 Events
|
9 Events
|
5 Events
|
5 Events
|
7 Events
|
5 Events
|
10 Events
|
13 Events
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). This OM was not a pre-specified outcome for all Bamlanivimab arms (Phase 2 \& 3) and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Measured by pulse oximeter and categorized as \<96% versus ≥96%. Analysis not performed for Bamlanivimab arms.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=91 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=93 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=100 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=97 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=90 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=91 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=98 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=92 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=106 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=101 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=45 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=44 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=119 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=98 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=91 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=89 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=90 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=182 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=178 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oxygen Saturation Level (Phases 2 and 3)
Oxygen Saturation ≥96%
|
89 Participants
|
90 Participants
|
99 Participants
|
95 Participants
|
87 Participants
|
87 Participants
|
95 Participants
|
90 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
94 Participants
|
45 Participants
|
—
|
94 Participants
|
42 Participants
|
111 Participants
|
96 Participants
|
89 Participants
|
88 Participants
|
88 Participants
|
177 Participants
|
171 Participants
|
|
Oxygen Saturation Level (Phases 2 and 3)
Oxygen Saturation <96%
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
0 Participants
|
—
|
12 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Oxygen Saturation Level (Phases 2 and 3)
Missing pulse oximetry records
|
12 Participants
|
18 Participants
|
10 Participants
|
13 Participants
|
16 Participants
|
13 Participants
|
6 Participants
|
11 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
10 Participants
|
—
|
6 Participants
|
7 Participants
|
15 Participants
|
9 Participants
|
11 Participants
|
16 Participants
|
17 Participants
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Thru Day 14Population: Analysis population description (Phase 2): mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Participants with missing or unsuitable samples were excluded from analysis. All placebo arms except for Bamlanivimab include pooled placebo data. This OM was not a pre-specified outcome for Bamlanivimab Phase 2 and therefore not done.
Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time. Not analyzed for Bamlanivimab arms.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=100 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=96 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=84 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=96 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=96 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=99 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=94 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=100 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=100 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=87 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=95 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=47 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=46 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=105 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
|
13.1472 units on a scale*days
Standard Deviation 13.34285
|
15.2756 units on a scale*days
Standard Deviation 12.81071
|
13.9833 units on a scale*days
Standard Deviation 13.85182
|
11.2405 units on a scale*days
Standard Deviation 12.06870
|
12.8663 units on a scale*days
Standard Deviation 14.03668
|
11.6766 units on a scale*days
Standard Deviation 11.40875
|
13.6064 units on a scale*days
Standard Deviation 14.17869
|
9.5 units on a scale*days
Standard Deviation 11.20
|
10.9 units on a scale*days
Standard Deviation 11.87
|
—
|
—
|
—
|
—
|
12.5 units on a scale*days
Standard Deviation 11.497
|
14.0 units on a scale*days
Standard Deviation 15.134
|
9.2 units on a scale*days
Standard Deviation 10.127
|
11.7 units on a scale*days
Standard Deviation 16.505
|
13.7450 units on a scale*days
Standard Deviation 11.03930
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Bamlanivimab Phase 3 enrolled under Protocol v1, this OM was a new addition in v7 for Phase 3 so this OM was not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=109 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=112 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
|
30 Participants
|
25 Participants
|
24 Participants
|
31 Participants
|
29 Participants
|
25 Participants
|
20 Participants
|
26 Participants
|
40 Participants
|
19 Participants
|
16 Participants
|
47 Participants
|
30 Participants
|
45 Participants
|
20 Participants
|
—
|
29 Participants
|
14 Participants
|
45 Participants
|
25 Participants
|
23 Participants
|
22 Participants
|
28 Participants
|
58 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Thru Week 24Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Bamlanivimab 700mg (Phase 3) enrolled under Protocol v1, this OM was a new addition in v7 for Phase 3 so this OM was not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=48 Participants
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=46 Participants
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=111 Participants
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=112 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=109 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=112 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=105 Participants
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=107 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
|
38 Participants
|
33 Participants
|
34 Participants
|
41 Participants
|
32 Participants
|
32 Participants
|
27 Participants
|
32 Participants
|
46 Participants
|
22 Participants
|
18 Participants
|
53 Participants
|
39 Participants
|
50 Participants
|
23 Participants
|
—
|
45 Participants
|
17 Participants
|
60 Participants
|
31 Participants
|
30 Participants
|
76 Participants
|
74 Participants
|
72 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Thru Week 24Population: Analysis population description: mITT analysis set = randomized and treated = all with randomization date - (randomized not treated + screen fail but randomized + excluded from analyses at NIH request + dual enrolled subject). Bamlanivimab Ph2 enrolled under Protocol v1, AZD7442, BMS enrolled under v6, this OM was a new addition for Phase 2 agents in v7 so this OM was not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=110 Participants
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=110 Participants
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=105 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=106 Participants
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=103 Participants
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=121 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
n=397 Participants
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=990 Participants
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=383 Participants
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=134 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=107 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=102 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=198 Participants
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=194 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
|
—
|
—
|
5 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
8 Participants
|
13 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
74 Participants
|
—
|
92 Participants
|
37 Participants
|
—
|
27 Participants
|
11 Participants
|
12 Participants
|
—
|
—
|
30 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Thru Day 28Population: Analysis population description: Number of subjects in analysis = participants who returned to usual (pre-COVID-19) health. Bamlanivimab Phase 2\&3 enrolled under v1, Camostat, SNG001, BRII, SAB Ph2 enrolled under Protocol v6 or earlier, OM was new addition in Protocol v8, not pre-specified and therefore not done. BRII-196+BRII-198 Placebo includes pooled placebo data.
Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary. Not collected for Bamlanivimab Phase 2 and Phase 3 arms.
Outcome measures
| Measure |
SNG001 Pooled Placebo (Phase 2)
n=103 Participants
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=111 Participants
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=121 Participants
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) (Phase 2)
n=134 Participants
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=105 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
AZD7442 (IM) (Phase 2)
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=55 Participants
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=51 Participants
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 Participants
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=194 Participants
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
Administered as oral tablets Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
Administered by inhalation SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
|
15.00 Days
Interval 11.0 to 19.0
|
15.00 Days
Interval 12.0 to 18.0
|
—
|
—
|
14.0 Days
Interval 10.0 to 16.0
|
15.0 Days
Interval 10.0 to 19.0
|
—
|
—
|
13.0 Days
Interval 10.0 to 17.0
|
—
|
—
|
—
|
—
|
—
|
13.00 Days
Interval 9.0 to 21.0
|
—
|
—
|
17.00 Days
Interval 9.0 to 21.0
|
17.0 Days
Interval 13.0 to 23.0
|
17.0 Days
Interval 15.0 to 20.0
|
15.0 Days
Interval 12.0 to 18.0
|
—
|
—
|
—
|
—
|
Adverse Events
Bamlanivimab 7000 mg (Phase 2)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Bamlanivimab 7000mg Placebo (Phase 2)
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Bamlanivimab 700mg (Phase 2)
Serious events: 5 serious events
Other events: 69 other events
Deaths: 0 deaths
Bamlanivimab 700mg Placebo (Phase 2)
Serious events: 4 serious events
Other events: 57 other events
Deaths: 0 deaths
Bamlanivimab 700mg (Phase 3)
Serious events: 57 serious events
Other events: 334 other events
Deaths: 12 deaths
BRII-196+BRII-198 (Pooled Phase 2/3)
Serious events: 25 serious events
Other events: 223 other events
Deaths: 2 deaths
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Serious events: 56 serious events
Other events: 228 other events
Deaths: 11 deaths
AZD7442 (IV) (Phase 2)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
AZD7442 (IV) Pooled Placebo (Phase 2)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 1 deaths
AZD7442 (IM) (Phase 2)
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
AZD7442 (IM) Pooled Placebo (Phase 2)
Serious events: 7 serious events
Other events: 40 other events
Deaths: 1 deaths
SNG001 (Phase 2)
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
SNG001 Pooled Placebo (Phase 2)
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Camostat (Phase 2)
Serious events: 9 serious events
Other events: 53 other events
Deaths: 1 deaths
Camostat Pooled Placebo (Phase 2)
Serious events: 7 serious events
Other events: 57 other events
Deaths: 1 deaths
SAB-185 (Low Dose) (Phase 2)
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Serious events: 10 serious events
Other events: 93 other events
Deaths: 1 deaths
Casirivimab and Imdevimab (Phase 3) OMICRON Population
Serious events: 13 serious events
Other events: 91 other events
Deaths: 4 deaths
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
Serious events: 11 serious events
Other events: 64 other events
Deaths: 4 deaths
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
Serious events: 10 serious events
Other events: 85 other events
Deaths: 1 deaths
SAB-185 (High Dose) (Phase 2)
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
SAB-185 (High Dose) Pooled Placebo (Phase 2)
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
BMS 986414+BMS 986413 (Phase 2)
Serious events: 7 serious events
Other events: 52 other events
Deaths: 0 deaths
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bamlanivimab 7000 mg (Phase 2)
n=48 participants at risk
Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 7000mg Placebo (Phase 2)
n=46 participants at risk
Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 2)
n=111 participants at risk
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg Placebo (Phase 2)
n=112 participants at risk
Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 participants at risk
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=390 participants at risk
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=390 participants at risk
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=55 participants at risk
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=51 participants at risk
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) (Phase 2)
n=103 participants at risk
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=111 participants at risk
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 participants at risk
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=110 participants at risk
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 participants at risk
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=105 participants at risk
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=103 participants at risk
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=194 participants at risk
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
n=121 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
n=134 participants at risk
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (High Dose) (Phase 2)
n=107 participants at risk
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=102 participants at risk
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 participants at risk
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 participants at risk
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Visual impairment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Generalised oedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Oedema peripheral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Anal abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Appendicitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Catheter site infection
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Cellulitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
COVID-19
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
17/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.7%
38/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.9%
3/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
6/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
7/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.0%
6/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Cystitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Sepsis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Septic shock
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Serratia bacteremia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Urosepsis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Pelvic bone injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood glucose increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Hyperglycaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Hyponatremia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/1 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Brain injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Coma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Migraine
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Seizure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Product Issues
Device leakage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Drug use disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Major depression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Fracture blisters
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Social circumstances
Physical assault
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Distributive shock
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Obstructive shock
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
Other adverse events
| Measure |
Bamlanivimab 7000 mg (Phase 2)
n=48 participants at risk
Administered by IV infusion.
bamlanivimab 7000mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 7000mg Placebo (Phase 2)
n=46 participants at risk
Administered by IV infusion
Placebo for Bamlanivimab 7000mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 2)
n=111 participants at risk
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg Placebo (Phase 2)
n=112 participants at risk
Administered by IV infusion
Placebo for Bamlanivimab 700mg: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
Bamlanivimab 700mg (Phase 3)
n=990 participants at risk
Administered by IV infusion
bamlanivimab 700mg: Administered by single IV infusion. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 (Pooled Phase 2/3)
n=390 participants at risk
Administered by IV infusion
BRII-196+BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
|
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
n=390 participants at risk
Administered by IV infusion
Placebo for BRII-196+BRII-198: Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) (Phase 2)
n=55 participants at risk
Administered by IV infusion
AZD7442 (IV): 300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
AZD7442 (IV) Pooled Placebo (Phase 2)
n=51 participants at risk
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IV): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) (Phase 2)
n=103 participants at risk
Administered by IM injection
AZD7442 (IM): Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
|
AZD7442 (IM) Pooled Placebo (Phase 2)
n=111 participants at risk
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Placebo for AZD7442 (IM): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SNG001 (Phase 2)
n=110 participants at risk
Administered by inhalation
SNG001: 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
SNG001 Pooled Placebo (Phase 2)
n=110 participants at risk
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Placebo for SNG001: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
|
Camostat (Phase 2)
n=106 participants at risk
Administered as oral tablets
Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
Camostat Pooled Placebo (Phase 2)
n=105 participants at risk
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Placebo for Camostat: 200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 2)
n=106 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
n=103 participants at risk
Administered by IV infusion; includes SAB-185 (high dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (low dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
SAB-185 (Low Dose) (Phase 3) OMICRON Population
n=198 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) OMICRON Population
n=194 participants at risk
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
* Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
n=121 participants at risk
Administered by IV infusion
SAB-185 (3,840 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
n=134 participants at risk
Administered by IV infusion
CASIRIVIMAB + IMDEVIMAB: 600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
* Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
* For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
|
SAB-185 (High Dose) (Phase 2)
n=107 participants at risk
Administered by IV infusion
SAB-185 (10,240 Units/kg): Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
|
SAB-185 (High Dose) Pooled Placebo (Phase 2)
n=102 participants at risk
Administered by IV infusion; includes SAB-185 (low dose) and placebo from other comparator arms in the study.
Placebo for SAB-185 (high dose): Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 (Phase 2)
n=105 participants at risk
Administered as subcutaneous (SC) injections
BMS-986414 + BMS-986413: Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
|
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
n=107 participants at risk
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Placebo for BMS-986414 + BMS-986413: Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Ear infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Granulocytosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Haemoconcentration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Nucleated red cells
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Atroventricular block first degree
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Palpitations
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Congenital, familial and genetic disorders
Hypermobility syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Congenital, familial and genetic disorders
Tourette's disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Mastoid disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Goitre
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Graves' disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Blepharitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Blepharospasm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Cataract
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Chalazion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Dry eye
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Eye irritation
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Eye pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Eye pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Eye swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Glaucoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Holmes-Adie pupil
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Macular hole
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Photophobia
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Presbyopia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Retinal detachment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Retinal tear
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Vision blurred
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Visual field defect
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Visual impairment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
5/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
5/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
6/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
13.0%
6/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
6/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
25/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
21/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
14/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
3/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.9%
5/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
11.8%
13/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.8%
5/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.0%
6/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
6/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.8%
5/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastrointestinal erosion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Nausea
|
12.5%
6/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
3/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
6/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
17/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
13/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
3/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.8%
5/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
4/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.0%
8/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Toothache
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
3/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.0%
4/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Adverse drug reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Application site hyperaesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Asthenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Chest discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Chest pain
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Chills
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.81%
8/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
7/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
4/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
6/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Complication associated with device
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Dehiscence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Discomfort
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Drug intolerance
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Facial pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Fatigue
|
12.5%
6/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.7%
4/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.2%
8/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.6%
16/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.1%
16/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
22/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
2/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.9%
3/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.0%
11/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.6%
7/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.7%
7/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.6%
13/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.6%
9/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.6%
8/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.7%
9/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.7%
7/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Feeling abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Gait disturbance
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Generalised oedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Inflammation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Influenza like illness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site bruising
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site extravasation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site induration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site paraesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion site reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Infusion stie pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site erythema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site haemorrhage
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site rash
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Injection site swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Malaise
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Oedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Oedema peripheral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Pain
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
6/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.61%
6/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
8/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.5%
9/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
4/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
6/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Peripheral swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Physical deconditioning
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Pyrexia
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
3/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.2%
8/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
19/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
11/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
7/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.8%
7/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
6/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Sensation of foreign body
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Swelling face
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Vaccination site pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
General disorders
Xerosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.61%
6/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Food allergy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Immunodeficiency common variable
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Iodine allergy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.71%
7/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Abscess limb
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Anal abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Appendicitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Bacterial pyelonephritis
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Body tinea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Bronchitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Candida infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Cellulitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Cervicitis gonococcal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
COVID-19
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.5%
33/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
25/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
19.1%
21/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.1%
10/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
11.3%
12/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
13.3%
14/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
12.3%
13/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.0%
8/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
7/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.4%
9/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
11.2%
15/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.5%
10/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Cystitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Dengue fever
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Epididymitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Eye infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Folliculitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Furuncle
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
HIV infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Hordeolum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Impetigo
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Influenza
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Kidney infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Laryngitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Localised infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Monkeypox
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Mycobacterium kansasii infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
13/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
11/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Oral herpes
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Orchitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Otitis externa
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Otitis media
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Ovarian abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Paronychia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Periodontitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
3/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Root canal infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Sepsis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Septic shock
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Shigella infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Sinusitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.71%
7/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
4/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.0%
4/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Syphilis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tinea infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Tooth infection
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
5/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
2/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.8%
5/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.81%
8/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Urosepsis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Viral infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Colon injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Foot fracture
|
4.2%
2/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
2/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
13/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
2/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Pancreatic injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Pelvic bone injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
9/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
14/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
3/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.9%
5/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.1%
10/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.7%
9/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
5/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.8%
8/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
7/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.8%
6/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.9%
5/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Biopsy cervix abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood acid phosphatase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood albumin decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood albumin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood bilirubin increased
|
4.2%
2/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood bilirubin unconjugated decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood calcium decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood calcium increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood chloride decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood chloride increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatine decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatine increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood creatinine increased
|
4.2%
2/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.9%
3/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.6%
15/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.2%
12/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
3/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood glucose decreased
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood glucose increased
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
35/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.6%
18/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.6%
18/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
4/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.7%
9/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
8/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.6%
21/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.3%
20/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.3%
10/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
11.2%
15/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood iron decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood magnesium increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood osmolarity increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood potassium abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood potassium decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood potassium increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood pressure increased
|
8.3%
4/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.61%
6/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood sodium abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood sodium decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.0%
6/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood sodium increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood urea decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood urea increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood urea nitrogen/creatinine ratio increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Blood zinc decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Body temperature increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Cardiac murmur
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
C-reactive protein increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
11/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Differential white blood cell count abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Eosinophil count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Full blood count abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Globulins increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Grip strength decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Haematocrit decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Haematocrit increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Haemoglobin abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Haemoglobin decreased
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
3/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Haemoglobin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Heart rate increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
HIV test positive
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Hypocalcaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Immature granulocyte count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Lipase increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Liver function test abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Liver function test increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Lymphopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Mean cell volume increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Neutrophil count abnormal
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Neutrophil count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Platelet count decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Platelet count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Procalcitonin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Protein total decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Protein total increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Red blood cell count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Respiratory rate increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Serum ferritin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Transaminases increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Transferrin saturation decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Troponin increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Urine output decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Vitamin B12 increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Vitamin D decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
Weight decreased
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
White blood cell count decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Investigations
White blood cell count increased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
5/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
13/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
14/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.8%
6/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
5/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
4/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.9%
5/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypertransaminasaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.71%
7/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
15/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.4%
17/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
8/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.6%
9/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.81%
8/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
5/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint space narrowing
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.4%
5/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.61%
6/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.81%
8/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Ageusia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.61%
6/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Amnesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Anosmia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
9/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Aphasia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Brain fog
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Brain injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Coma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Disturbance in attention
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.81%
8/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.3%
9/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Head titubation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Headache
|
10.4%
5/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
13.0%
6/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.2%
8/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.0%
9/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
29/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.9%
31/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.7%
34/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
4/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
2/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.0%
11/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.1%
10/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.5%
9/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.8%
7/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.0%
8/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.9%
7/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Migraine
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Parosmia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Presyncope
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Sciatica
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Seizure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Somnolence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Tension headache
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Tremor
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Ulnar nerve palsy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Labour pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Product Issues
Device leakage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Abulia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Aggression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Agitation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Depression
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
3/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Impaired reasoning
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
5/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.1%
16/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.1%
12/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
7/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Psychiatric disorders
Tobacco abuse
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
4/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Penile dermatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Penile discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
4/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
3/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
5/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
17/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.4%
17/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.4%
17/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.8%
6/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.9%
12/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
7/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.6%
7/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.1%
8/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.6%
8/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
8.2%
11/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.5%
3/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.4%
6/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.1%
8/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.4%
14/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.9%
19/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.8%
7/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
10.0%
11/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
6.4%
7/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.7%
6/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.1%
6/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.1%
11/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.0%
12/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
2/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.71%
7/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
7/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
9/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
5/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.0%
6/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal cobble stone mucosa
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
9/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.1%
16/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
4/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.5%
3/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.0%
4/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.6%
6/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.9%
4/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
4/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
2/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.2%
12/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
8/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
6/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
2/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.5%
6/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.5%
7/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.1%
4/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.3%
4/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.5%
6/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
4/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.71%
7/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.6%
10/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.3%
8/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.8%
3/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.7%
2/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.7%
5/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
7.5%
8/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.30%
3/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Fracture blisters
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.40%
4/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.3%
5/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
3/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.5%
2/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.98%
1/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.1%
1/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
2/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.91%
1/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Urticaria cholinergic
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Social circumstances
Victim of crime
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.20%
2/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.83%
1/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Ecchymosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Flushing
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.89%
1/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Haematoma
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hot flush
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.94%
1/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hypertension
|
6.2%
3/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.3%
2/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.1%
11/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
15/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.6%
18/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
1/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.0%
1/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.8%
2/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.7%
3/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.6%
4/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
3.8%
4/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.8%
5/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.0%
8/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.6%
9/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
5.8%
7/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
9.7%
13/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.9%
3/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
4.7%
5/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Hypotension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
2.2%
1/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.10%
1/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.77%
3/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.9%
2/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.90%
1/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
1.0%
2/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.52%
1/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Obstructive shock
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Phlebitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.93%
1/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.95%
1/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.26%
1/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.51%
1/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.75%
1/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/48 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/46 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/112 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/990 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/390 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/55 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/51 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.97%
1/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/111 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/110 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/106 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/103 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/198 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/194 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/121 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/134 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/102 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/105 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
0.00%
0/107 • Week 24 for Bamlanivimab arms. Week 72 for all other arms.
Safety Analysis Set: randomized and treated=all with randomization date - (randomized not treated+screen fail but randomized+excluded from analyses at NIH request+dual enrolled subject). Summarized by actual treatment received. 8 participants allocated to BRII Placebo arm received active treatment. Pooled placebo except Bamlanivimab, SAB (Phase 3) and Casirivimab+Imdevimab (Phase 3) arms. SAEs=Serious Treatment Emergent Adverse Events (TEAEs) Other (non-Serious) AEs=Other (non-Serious) TEAEs
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, DLH
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER